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|March 21, 2013 8:00 a.m.|
|Early versus Delayed Treatment with Laquinimod Demonstrated Significant Reduction in Risk of Disability Progression – Results of Three-Year ALLEGRO Study in Relapsing-Remitting Multiple Sclerosis|
Of the 864 RRMS patients who participated in the original double-blind ALLEGRO trial, 97% participated in the open-label extension and 87% completed one year of the open-label phase. Overall, during the entire conduct of the study (double blind and open label phase), early start patients were less likely to experience disease progression than those with a delayed start of Laquinimod (11.8% risk of confirmed disability progression vs 16.7%, HR = 0.62, p < 0.0038).
“The results of this longer-term study of laquinimod suggest a robust benefit in terms of early treatment for RRMS and in potentially delaying disability, which is a primary goal of RRMS treatment,” said Dr.
The study also supports a favorable safety and tolerability profile of laquinimod in RRMS patients. No new safety concerns arose during the open-label phase.
Additionally, a preclinical study in animal models demonstrated the ability of laquinimod to increase the myelinated axons and mature oligodendrocytes in the brain. This data suggests laquinimod has potential restorative and anti-inflammatory properties.
Results of both studies will be shared with the scientific community following a full analysis of the data.
ABOUT THE STUDIES
[S41.004] Comparison of Early and Delayed Oral Laquinimod in Patients with Relapsing-Remitting Multiple Sclerosis: Effects on Disability Progression at 36 Months in the ALLEGRO Trial
[P05.197] Therapeutic Laquinimod Treatment Restores Axon Myelination, Callosal Conduction and Motor Deficit in a Chronic Mouse Model of Multiple Sclerosis
Laquinimod is an oral, once-daily CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of MS. In animal models laquinimod crosses the blood brain barrier to potentially have a direct effect on resident CNS inflammation and neurodegeneration. The global Phase III clinical development program evaluating oral laquinimod in MS includes two pivotal studies, ALLEGRO and BRAVO. A third Phase III laquinimod trial, CONCERTO, is evaluating two doses of the investigational product (0.6mg and 1.2mg) in approximately 1,800 patients for up to 24 months, after which patients will continue to an active treatment period with laquinimod for additional 24 months The primary outcome measure will be confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS).
In addition to the MS clinical studies, laquinimod is currently in clinical development for Crohn's disease and Lupus.
ABOUT MULTIPLE SCLEROSIS
MS is the leading cause of neurological disability in young adults. It is estimated that more than 400,000 people in
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